GUEST COLUMNISTS

• Rare Diseases: How To Leverage Social Media For Patient Analysis

  Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.

• FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products

  At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

• Medtech Innovation: 3 Strategies For Leveraging Agile Methodologies

  While medtech firms have had proven success with scaling and short bursts of innovation from special projects and acquisitions, many firms have struggled to achieve a steady stream of disruptive innovation. This article provides three strategies for leveraging agile methodologies for better innovation.

• eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?

  When the pandemic started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Now, as the U.S. is in a summer characterized less by COVID and more by time spent with family and friends, are we willing to face COVID’s hard lessons?

• Designing A Patient-Centric Digital Ecosystem: Strategies For Cell And Gene Therapy CxOs

  Cell and gene therapy (CGT) production is costly, complex, and high-risk; in part, because most supply chain and manufacturing processes involve multiple stakeholders and facilities. In the first article of this series we discussed how CGT adoption and success hinges on early planning to scale manufacturing and supply. This article describes strategies to enable a patient-centric digital ecosystem and capabilities to support CGTs before, during, and after the order life cycle.

• Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book

  The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.

• 4 Lessons For AI In Medtech: Case Studies From Breast Cancer Detection

  Recent advances in artificial intelligence (AI) and machine learning, especially deep learning, are poised to help further advance many medical fields. One of the physicists involved in helping advance breast health solutions through AI shares his 4 lessons learned in working with AI in mammography technology, and those lessons can be applied to many other medtech fields.

• How To Enhance “Operational Learning” In Biopharma

  According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.